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Navigating the complex challenges of medical device manufacture requires a safe pair of hands as you juggle risks, challenges, constraints and uncertainty. IDE Group has been at the forefront for over two decades.
When the Food and Drug Administration's (FDA) Quality Management System Regulation (QMSR) took effect. QMSR amended 21 CFR 820 with a framework aligned to ISO 13485:2016. Buried in that shift is a quieter change, one that matters enormously if you're developing medical devices for both the US and Europe. Usability engineering stopped being two separate conversations.
A clinician using a medical device interface should not have to pause, guess or recover from preventable confusion. Every screen needs to assist them in making the right decision safely, quickly and with confidence.




